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Catheter Sterilizing

One Unique Idea Is Poised to Upend an Industry

By Jolene Montgomery

Souvik Paul is a patient man. After all, he has spent a lifetime explaining that Paul is his last name, and yes, Souvik (Soh-vick) is his first. Along with patience, he possesses dedication to an ideal, and that is what causes him to leap in when he sees a system is broken.

Souvik was a Harvard undergrad when, on a whim, he took a class in the Harvard Graduate School of Design. "That's where I realized there is a whole world of design that doesn't fit what I typically thought of as 'design'."

After graduating from Harvard, Souvik worked as a trader at JP Morgan Chase. It was 2012. Companies such as Apple and Tesla were showing the world that the physical design of products like the iPhone and desirable electric cars could change people's lives. Knowing that he didn't want to work in finance for the rest of his life, Souvik began to wonder if he had what it takes to become a designer whose work could help people live richer and fuller lives.

The 'whim' that led him to that class at Harvard ultimately became a career shift that took him to the School of Visual Arts in NYC, where he found a program called Products of Design.

"Nowhere else had I seen design developed from the user's perspective! It was ground breaking, and exactly where I wanted to go."

Life-Changing Accident Focuses Desire to Help

It was at this time that a life-changing event hit him. Souvik's girlfriend's sister, Carina, suffered a car crash that left her paralyzed. Souvik went on the life journey with her.

"I spent time in hospital in San Jose," Souvik remembers, "going through the critical stages of Carina's injury, then the difficult stages of rehab and recovery. We were facing the realities of SCI in a system that is broken."

"In contrast, the optimism of grad school was a jarring change from the suffering at home. The only way I could reconcile that dichotomy was to focus on design for SCI. After all, I wanted to become a designer to ultimately help people, right? So I asked the question: is design a methodology that can ultimately help people in pain?"

Souvik learned everything he could about disability and SCI in a realistic setting by speaking to everyone he could—surgeons, doctors, occupational therapists and individuals with SCI.

If You Don't Catheterize, You Don't Realize

"Carina only got 110 catheters/month and, as a result, had to reuse her catheters, which led to a ton of infections. I learned that the odds of getting a UTI is 40-60% in the first 12 months after injury. Ask a doctor about that and they will say that patients need to follow the catheterization guidelines. I would challenge any of those doctors to follow the catheterization guidelines! There is a standard out there, but no one can possibly follow it."

Not willing to be a hypocrite, Souvik tried catheterizing himself. "I can't say it was exactly comfortable," he admits, "But I couldn't design something without trying it myself or I would have zero credibility. If you don't catheterize, you just don't realize."

"It is all well and good to say, 'follow the catheterization guidelines', but you have no idea until you actually try it. They call it 'sterile procedures', which requires gloves and Betadine and using a catheter without letting it touch your hands or any part of your body! Even if you manage to do it, it can't be done quickly. How do you hold down a job and do that 6 times a day? It simply isn't feasible in today's professional environment."

Introducing Revolutionary Product to Sterilize Catheters

Having learned as much as he could about SCI and the current state of catheterization and catheter reuse, Souvik designed a portable catheter sterilizer for his final thesis project at SVA. Called CathBuddy, it uses light to disinfect used silicone catheters and would allow anyone who didn't get enough catheters from their insurance provider to safely extend the longevity of the ones they have.

After graduating from SVA, Souvik would go on to work at Johnson & Johnson as a design strategist, while continuing to work on CathBuddy at the SVA Groundfloor Incubator. He joined forces with a friend who was at Tufts University and applied to the $100K New Ventures Competition at Tufts. They won First Place and $15K in the medical device category! As they continued to work on the business model that could help make CathBuddy a reality, they suspected, however, that FDA wouldn't approve a device that enables a patient to reuse catheters, when the FDA guidelines say the opposite.

"We knew that there is a wavelength of light that sterilizes pathogens that can make safe reuse of catheters possible. We also knew that people, regardless of whether they reused their catheters or not, were getting sick all the time from catheterization. There was the challenge, right in front of us: Usability vs. Reusability. We knew that there's an entire world of catheter products out there, some that are easier to use than others. The problem is that those easier to use products are 5 to 7 times the cost of the basic ones. So there's the answer: use design to develop an easy-to-use catheterization system that is reusable and therefore affordable!"

But what about the FDA, and the inevitable backlash from the other catheter companies?

Souvik acknowledges the challenges ahead. "The entire market is single-use right now." he agrees. "The way we see it, if we can get people asking for safely reusable, high quality, and easy-to-use catheters, then like it or not, the other companies can't change the fact that it is out there. They'll be forced to deliver innovative solutions to users even though it might completely upend their business model. And we see that as totally necessary—the current state-of-the-art solutions just aren't helping people because they are just too expensive. Insurance won't pay for them."

CathBuddy Needs Your Two Cents

Souvik will be at the Abilities Expo in New Jersey to introduce his exciting invention and get the responses from the people it affects most—the end users themselves.

"It is important for designers to see feedback. Also, for investors it is important that we can point to the data from the Abilities Expo and show that we had this many people sign up on our website, this many people fill out questionnaires, etc. The Expo is our opportunity to have a model of what the system looks like; to talk to people and get feedback.

Souvik's plan is to submit their application to the FDA in the first quarter of next year, which means that CathBuddy could be on the market as soon as the first quarter of 2021.

"Currently the catheter sterilization process takes only 5-10 minutes, and up to 6 catheters can be simultaneously sterilized in the at-home sterilizer. Combine that with our unique design that enables a person to self-cath without the contortions of 'sterile procedures', and we think we have a solution that works!"

At 29, Souvik's goals are still more philanthropic than acquisitive. "These whole processes—of relearning how to urinate or defecate after sustaining an SCI—are really impactful on a person's sense of their own self-worth. If you don't know anyone who has gone through a bowel program you aren't going to understand, but someone's sense of personhood and dignity is at stake here."

"We believe it is a big enough problem to keep working on it. And even If we don't succeed, somebody will. That's more important than the money."

You can sense Souvik's frustration when he asks, rhetorically, "Do you know the number of people I've talked to who prophylactically take antibiotics? People are making themselves sick over a relatively simple problem. That's where we are coming from—that's why we are doing this."

Come talk to Souvik and see the CathBuddy prototype in booth #943 at the NJ Abilities Expo, May 3-5, Edison, New Jersey, and sign up on www.cathbuddy.com for product updates!